NSA
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Over-The-Counter Automated External Defibrillator
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.5310
- Medical specialty
- Cardiovascular
- Flags
- Life-sustaining
- FDA definition
- Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.
- Adverse events (MAUDE)
- 2021: 20 · 2022: 23 · 2023: 67 · 2024: 92 · 2025: 573 · 2026: 372
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A (K040904) | Philips Medical Systems | 2004-09-16 |
Track NSA automatically
Every clearance here is in the API, with alerts when new ones post.